MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Model Number	5085 SURGICAL TABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite and learned that at the time of the reported event the 5085 surgical table was in trendelenburg position, and the tabletop began to slide in a downward direction without being commanded to do so.The table was removed from service for evaluation by the user facility's biomed department.The table and gear box were disassembled prior to the technician's arrival.The technician found that the slide motor and gear box were found to have broken teeth.As the gears were damaged, this prevented the tabletop from remaining locked resulting in the reported event.An exact cause of the damage to the gears could not be determined.The user facility is pending the necessary repairs on the table before returning the damaged parts back to steris for evaluation.A follow up will be submitted should additional information become available.
Event or Problem Description
The user facility reported via medwatch report mw5116422 that during a patient procedure the tabletop to their 5085 surgical table began to move in an uncontrolled manner.The procedure was completed successfully.No report of injury or procedure delay.
Additional Manufacturer Narrative
The user facility made the necessary repairs to the 5085 surgical table, and it was returned to service.The damaged parts subject of the reported event will not be returned to steris for evaluation.Without the returned parts, an exact root cause could not be determined.No additional issues have been reported.

• Brand Name: 5085 SURGICAL TABLE
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16867392
• Report Number: 1043572-2023-00097
• Device Sequence Number: 12251622
• Product Code: FQO
• UDI-Device Identifier: 00724995154875
• UDI-Public: 00724995154875
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5085 SURGICAL TABLE
• Device Catalogue Number: ST014101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown